STIMULEN COLLAGEN

K030774 · Southwest Technologies, Inc. · KGN · Aug 9, 2004 · SU

Device Facts

• Record ID: K030774
• Device Name: STIMULEN COLLAGEN
• Applicant: Southwest Technologies, Inc.
• Product Code: KGN · SU
• Decision Date: Aug 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Stimulen™ Collagen is indicated for prolonged use (24 hr to 30 days) in the management of wounds including: full and partial thickness wounds, pressure ulcers (stages I-IV), venous stasis ulcers, diabetic ulcers, partial thickness burns, acute wounds, abrasions, traumatic wounds healing by secondary intention, donor sites and other surface wounds.

Device Story

Stimulen™ Collagen is a sterile, single-use wound dressing composed of soluble modified bovine collagen. Supplied as powder, gel, or gel sheet; applied directly to wound surface. Collagen dissolves in warm wound exudate to facilitate management of various wound types. Used in clinical settings for prolonged periods (24 hours to 30 days). Dressing provides a moist environment to support healing. Benefits include biocompatibility and biodegradability, aiding in the management of chronic and acute wounds.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including chemical analysis (amino acid composition, trace metals), bioburden analysis (<100 c.f.u.), and biocompatibility testing (Primary Skin Irritation, Acute Systemic Injection, Intracutaneous Test).

Technological Characteristics

Soluble modified bovine collagen. Forms: dry particulate powder, amorphous gel, gel sheet. Sterilization: SAL 10^-6 per AAMI/ISO 11137. Biocompatible, biodegradable. No electronic or software components.

Indications for Use

Indicated for management of full/partial thickness wounds, pressure ulcers (stages I-IV), venous stasis ulcers, diabetic ulcers, partial thickness burns, acute wounds, abrasions, traumatic wounds healing by secondary intention, and donor sites in patients requiring wound management.

Predicate Devices

• Medifil™ (K910944)
• hyCure™ (K955506)
• Collatek™ (K012990)
• HeliDerm™ (K990086)

Submission Summary (Full Text)

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Image /page/0/Picture/23 description: The image shows the logo for Southwest Technologies Inc. The logo consists of a circular emblem with a stylized "S" containing a flask inside. To the right of the emblem is the company name, "southwest technologies inc." in a sans-serif font, followed by the tagline "treating the world well" in a smaller font.

AUG - 9 2004

Ko30774
(letterhead)
510(k) Summary

# STIMULEN™ COLLAGEN

Safety and effectiveness information submitted in accordance with 21CFR § 807

# Submitter/ Contact Person:

Edward I. Stout, President Southwest Technologies, Inc. 1746 Levee Road N. Kansas City, MO. 64116

| Telephone: | [phone] |
|------------|------------------|
| Fax: | [phone] |
| email: | [e-mail] |

July 1, 2004 Date prepared:

## Device Name and Classification

Stimulen™ Collagen Proprietary Name: Wound Dressing Common Name: Classification Name: Classification:

#### Manufacturer

Southwest Technologies, Inc. 1746 Levee Road N. Kansas City, MO. 64116

## Substantial Equivalence Claim

Medifil™ by BioCore (K 910944) hyCure™ by Hymed Group (K955506) Collatek™ by BioCore (K012990) HeliDerm™ by Integra (K990086)

#### Device Description

Stimulen™ Collagen is a sterile primary single use dressing comprised of soluble modified bovine collagen base. The Stimulen™ collagen is soluble in the wound fluid and supplied as a powder or gel or sheet.

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#### Intended Use

Stimulen™ Collagen is indicated for the management of wounds including full and partial thickness wounds, pressure ulcers (stages I-IV), venous stasis ulcers, partial thickness thickness wounds, pressure uters (stages I-V), vehous stable and and other sites and other surface wounds.

# Comparison to Predicate Devices

| Device Name | Stimulen™ | Medifil™ | HyCure™ | Collatek™ | HeliDerm™ |
|------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Southwest Tech. | BioCore | Hymed Group | BioCore | Integra |
| Indications<br>For use | Prolonged use in<br>The management of<br>Full and partial thick-<br>Ness wounds. | Used to manage<br>Full and partial<br>Thickness wounds<br>with minimal to<br>Heavy exudate. | Used in the<br>Management<br>of chronic and<br>Acute wounds. | Used to manage<br>full and partial<br>Thickness wounds<br>With moderate to<br>Heavy exudate. | Used in the<br>Management of<br>Moderately to<br>Heavily exudating<br>Wounds and the<br>Control of minor<br>Bleeding. |
| Material | Soluble modified<br>Collagen | Type I Collagen | 96% derived from<br>Type I Collagen | Type I Collagen | Type I Collagen |
| Collagen<br>Source | Bovine | Bovine | Bovine<br>Flexor Tendon | Bovine | Bovine<br>Flexor Tendon |
| Biodegradable | Yes | Yes | Yes | Yes | Yes |
| Bio-<br>Compatibility | Yes | Yes | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes | Yes | Yes |

Technological characteristics:

- Stimulen™ Modified Collagen is a dry particulate powder. which will dissolve I. in warm wound exudate
- Stimulen is also supplied as an amorphous gel. II.
- Stimulen is also supplied as a gel sheet. III.

#### Safety

Chemical analysis indicated the amino acid composition are essentially equivalent to the HyCure collagen. Elemental metal analysis also shows the similar levels of trace metals.

Bioburden analysis of the non-sterile Stimulen showed low levels of contamination, less than 100 c.f.u. Biocompatibility tests, Primary Skin Irritation Test, Acute Systemic Injection Test, Intracutaneous Test demonstrated the Stimulen collagen to be non-toxic and non-irritating.

## Sterility and Packaging

Stimulen™ Modified Collagen will be packaged in a suitable container(vial, bottle, pouch). The container and contents will be sterilized at an SAL of 10 " in accordance with AAMI/ISO 11137.

#### Conclusion

Stimulen™ Modified Collagen is essentially equivalent in design, function, source of substrate materials, and indicated use, to the commercially available predicate devices, and therefore meets the requirements as defined in 21 CFR § 807.

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Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized emblem featuring three curved lines that resemble a bird in flight or a flowing design. The emblem is black, and the text is also in a dark color, contrasting with the likely white or light background of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2004

Dr. Edward I. Stout President Southwest Technologies, Inc. 1746 Levee Road N. Kansas City, Missouri 64116

Re: K030774

Trade/Device Name: Stimulen™ Collagen Regulatory Class: Unclassified Product Code: KGN Dated: July 1, 2004 Received: July 6, 2004

Dear Dr. Stout:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) prematics is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have decembled the arrested predicate devices marketed in interstate for use stated in the enclosure) to regally manced provide Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the character with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provinces of the Act . The and Cosmetic Act (Act) that do not require approvate of the general controls of the Act. The
You may, therefore, market the device, subject to the general posicstion, listi You may, therefore, market the device, subject to the most registration, listing of
general controls provisions of the Act include requirements for annual registrations ond general controls provisions of the receive requirementalibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entisting and to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Feactar Regarines
publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a succession in ther requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decemmanon that your and your Federal agencies. You must of any Federal statutes and regulations and including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, montag, contracturing practice requirements as set a CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forin in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dr. Edward I. Stout

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to oegin manteang your antial equivalence of your device to a legally premarket notification. The FDA midning of backandal vip.
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your as 101) 594-4659. Also, please note the regulation entitled, comact the Office of Comphalled as (Se notification" (21CFR Part 807.97). You may obtain Misblailing by reference to premientonibilities under the Act from the Division of Small other general information of your respective at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): _K030774 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Stimulen™ Collagen is indicated for prolonged use (24 hr to 30 days) in the management of wounds including:

- ·full and partial thickness wounds
- ·pressure ulcers (stages I-IV)
- •venous stasis ulcers
- ·diabetic ulcers
- ·partial thickness burns
- ·acute wounds
- ·abrasions
- •traumatic wounds healing by secondary intention
- •donor sites and other surface wounds

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_KO30774_________________________________________________________________________________________________________________________________________________________